A A A

Eytofen (Ophthalmic Solution)

COMPOSITION

Each ml contains:
Ketotifen fumarate equivalent to Ketotifen………0.25mg. with: Thiomersal, sodium chloride, glycerine and purified water.

CLINICAL PHARMACOLOGY

Ketotifen is a relatively selective, non-competitive histamine antagonist (H1-receptor) and mast cell stabilizer.Ketotifen inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and activation of eosinophils has also been demonstrated. Ketotifen has been shown to have little systemic exposure following topical ocular administration. A study conducted with 15 healthy volunteers dosed bilaterally with ketotifen fumarate ophthalmic solution twice daily for 14 days demonstrated plasma concentrations generally below the quantitation limit of assay (<20 pg/ml).In human conjunctival allergen challenge studies, ketotifen was significantly more effective than placebo in preventing ocular itching associated with allergic conjunctivitis. The action of ketotifen rapidly with an effect seen within minutes after administration.

INDICATIONS

Eytofen eye drops is indicated for the relief of the signs and symptoms of allergic conjunctivitis.

CONTRAINDICATIONS

Hypersensitivity to any component of the medication.

ADVERSE REACTIONS

Transient stinging and burning of the eye have been commonly reported while other manifestations of local irritation such as congestion, swelling and itching are rare. Blepharitis and dermatitis of the eyelid may occur and require discontinuation of treatment.

PREGNANCY AND LACTATION

Animal studies with systemic, ketotifen have shown no embryotoxic or teratogenic potential. However, ketotifen has not been studied in human pregnancy or lactation and its use is therefore not recommended in these situations except for compelling reasons.

Use in children: Safety and effectiveness in pediatric patients below the age of 3 year have not been established.

Overdosage: It is unlikely since a 5 ml bottle contains an amount of ketotifen, significantly lower than the recommended daily dose of oral ketotifen.

DOSAGE

One drop into the conjunctival sac(s) 2 to 3 times daily or according to the prescription of your ophthalmologist.

HOW SUPPLIED

Eye drops is available as a sterile solution in 5 ml pilfer proof plastic dropper bottles (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store below 25°C. Once opened use within 4 weeks.